Coformulated ombitasvir OBV paritaprevir PTV rironavir r 25150100 mg QD 2 tablets Dasabuvir DSV 250 mg bid Objective SVR 12 HCV RNA lt 25 IUml TURQUOISEIII ID: 427920
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Slide1
Treatment regimensCo-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) :25/150/100 mg QD = 2 tabletsDasabuvir (DSV) : 250 mg bid
ObjectiveSVR12 (HCV RNA < 25 IU/ml)
TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis
OBV/PTV/r
+ DSV + RBV
Open-label
≥ 18 yearsHCV genotype 1bHCV RNA > 1,000 IU/mlNaïve or pre-treatedNo prior therapy with PINon decompensated cirrhosis*Child-Pugh A
* Liver biopsy with Metavir > 3 or Ishak > 4, or Fibroscan > 14.6 kPa
N = 60
SVR
12
W12
W24
Design
Feld JJ. J Hepatol 2016; 64:301-7
TURQUOISE-IIISlide2
N = 60
Mean age, years
60Female
38%
Race : black
12%
Body mass index, mean
27.8
IL28B non-CC genotype
83%
HCV RNA log
10
IU/ml, mean (SD)
6.6 ± 0.6
Fibroscan
,
kPA
, median (range)
19 (12.5-67.8)
Prior treatment with PEG-IFN + RBV, N (%)
33 (55%)SVR12100%
Baseline characteristics and outcome
TURQUOISE-III
TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis
Feld JJ. J Hepatol 2016; 64:301-7Slide3
N = 60
Any adverse event
46 (77)AE leading to treatment discontinuation
0
Serious adverse event
1 (2)
AE occurring in
> 10%
Fatigue
22%
Diarrhea
20%
Headache
18%
Arthralgia
10%
Dizziness
10%
Insomnia
10%
Pruritus
10%
Hemoglobin
8-10 g/dl
1 (2)
ALT x 5-20 ULN1 (2)AST x 3-5 x ULN1 (2)
Adverse events, N (%)
TURQUOISE-III
TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis
Feld JJ. J Hepatol 2016; 64:301-7Slide4
SummaryOBV/PTV/r FDC + DSV, without the use of RBV, given for 12 weeks achieved SVR12 of 100% in genotype 1b infected patients with compensated cirrhosis, including treatment-experienced patientsTreatment was very well tolerated, with a low rate of serious adverse events, no premature discontinuations, and infrequent laboratory abnormalities that were not clinically relevantTURQUOISE-IIITURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir
+ dasabuvir for genotype 1b with cirrhosisFeld JJ. J Hepatol 2016; 64:301-7